Letter to Congressional Peeps
I am a small vape shop owner in Tampa, Florida. I am really concerned of recent actions taken by the FDA concerning flavored vape juice. In 2016 FDA deemed vaping products as (Electronic Nicotine Delivery Systems) under the Tobacco Control Act of 2009. In the 499 pages of deeming regulations and subsequent rules and enforcement by the FDA we have learned that the FDA is attempting to regulate vaping products like they do cigarettes. This is totally unrealistic and unfair to 10,000 plus small businesses who manufacture or sell vape products. The user fees and research cost are astronomical, $300,000 to $1,000,000 per sku. While billion-dollar foreign companies may be able to afford this, small businesses are having a hard time paying this to have shot of being approved for a marketing order.
This overbearing regulation was brought into litigation by the American Association of Pediatric Doctors. A judge has ruled in the case that the FDA must move forward in the application process with the filing of the Pre-Market Tobacco Application, deadline was September 8,2020. As the deadline drew near the FDA was overwhelmed with 6.5 million sku’s filed for. As we approach the court-imposed deadline for approvals of September 8,2021 some company’s applications haven’t been reviewed by the FDA. Other companies are reporting that they had to make corrections with the overburdensome filing requirements. And within the last week Marketing Denial Orders were sent out to several companies without explanation but the sku’s that were denied were all flavors other than tobacco.
I believe, as well as most of the industry, that this is a de facto flavor ban not based on science but based on politics. The FDA is ignoring independent research and making public health decisions based on faulty or misdirected research. According to Cochran library TAG (https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub5/full) e-cigarettes are twice as efficient than any other Nicotine Replacement Therapy. Public Health England reports that vaping is at least 95 percent safer than smoking cigarettes and has reported so since 2016. Even former FDA Director Dr. Scott Gottlieb has stated that “If you could take every adult smoker and fully switch them to e-cigarettes, that would have a substantial public health impact”. Another independent group Society for Research on Nicotine and Tobacco recently released:
Warner and 14 other past presidents of the Society for Research on Nicotine and Tobacco co-authored an article that argues that the media, legislators, and the general public have developed a negative view of e-cigarettes because of the heavy emphasis public health organizations have placed on protecting kids from vaping while ignoring the potentially substantial benefits of e-cigarettes in helping adults quit smoking. The article is published online in the American Journal of Public Health.
Based on this and numerous other articles and research why is the FDA promoting a de facto flavor ban when adults over 21 years of age prefer flavors other than tobacco by 90+ percent. (Based on sales in my store it is 95%). This is not only illogical but indicates other factors at play. We need some restraint on the FDA to let adults choose their methods and flavors. The FDA needs to base decision and regulations on science, not the claims of protecting the children. We need the legislature to make enforcement of T-21 laws a priority. Prohibition did not work for alcohol and will not work for vaping, except to make it much more dangerous for the user.
The FDA is not able to complete their work, as outlined by them, in a timely fashion. This is because the paperwork required for submission is totally off the chart. The requirements for testing and reporting of the testing is going to be overwhelming for most of the small businesses in the industry. While I don’t have to get approvals for running a retail store I will be forced to shut down if flavors are banned. Numerous online surveys have indicated that people will go to the black market or revert to smoking. 480,000 people die each year from smoking related diseases, it is despicable that certain groups are trying to prevent the most effective method of reducing the harm from combustible cigarettes all because teenagers are using the product illegally.
I will end with a quote from Clifford E. Douglass, J.D. “The primary target of tobacco control should be ending the unnecessary suffering and premature death caused by cigarettes and other combustible tobacco products, as prioritized in a major report from the American Cancer Society in 2018.” (https://drive.google.com/file/d/1C1nk1XEZ8WhnOXtCGTqHdeqomc9HOuko/view)
Senator/Representative we need your help to reduce the number of deaths from smoking.
 https://www.c-span.org/video/?452001-1/fda-commisioner-scott-gottlieb-discusses-cigarettes-public -health-concerns, September 25, 2018.